12 days old

Regulatory Affairs Senior Specialist

GE Energy
Marlborough, MA 01752
Role Summary:Position supports post and preapproval regulatory affairs with a focus on coordination of annual reports and PADERs. Supplemental application and amendment support for NDAs, ANDAs, and DMFs may also be required. You will work with the extended GE Healthcare team to gather and coordinate reviews of the information needed to support these RA US FDA filings.

Essential Responsibilities:



+ Project manage, route and collate PADERs and annual reports for all GE Healthcare Pharmaceutical Diagnostics (PDx) products



+ Support preparation of other US and Canada (USCAN) filings as needed



+ With the broader GE Healthcare team, develop well organized, complete and compliant post approval submissions for NDAs, ANDAs, and DMFs.



+ Maintain current knowledge and awareness of US legislation and FDA regulations/guidance that impact post approval regulatory affairs



+ Complete assigned training and maintain up-to-date knowledge and understanding of current company and department procedures and working practices



+ Maintain working knowledge of required job systems and processes and prepare working practice and SOP updates as assigned for USCAN-RA



+ Handle special projects as assigned



+ Support for other USCAN RA work as appropriate



Quality Specific Goals





+ Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type / position.



+ Complete all planned Quality & Compliance training within the defined deadlines.



+ Identify and report any quality or compliance concerns and take immediate corrective action as required.



+ Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility.







Qualifications/Requirements:



+ Bachelors degree or minimum 3 years progressive experience



+ Able to work in diversified team environments to leverage a broad viewpoint on problem resolution



+ Able to prioritize multiple tasks and escalate conflicts appropriately



+ Able to develop objective analyses, evaluate options & recommend solutions to management



+ Able to communicate deficiencies to discipline experts (e.g. CMC and Pharmacovigilance)



+ Able to write internal correspondence that describes SOP gaps or deficiencies



+ Able to perform crisis assessments & risk-benefit analysis







Desired Characteristics:



+ Bachelors degree in math or science



+ Strong analytical thinking capability



+ 4 or more years of pharmaceutical post approval regulatory affairs experience preferred



+ Organized and delivery focused



+ Ability to manage and prioritize multiple competing priorities and complete tasks on-time



+ Self-starter



+ Ability to make sound business judgments



+ Ability to set and make clear priorities







About Us:With 4000+ employees serving 100+ countries, GE Healthcares Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used in medical imaging exams to improve the visibility of organs, blood vessels or tissues, often helping radiologists distinguish between normal and abnormal conditions. PDx products makes a huge impact worldwide - supporting three patients every second.

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.

Additional Eligibility Qualifications:GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).Additional Locations:United States;Illinois, Massachusetts;Marlborough, Arlington Heights or Field Based;

Categories

Posted: 2020-10-13 Expires: 2020-11-12

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Regulatory Affairs Senior Specialist

GE Energy
Marlborough, MA 01752

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